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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Welch Allyn, Inc. - 00732094230253

67MCXP VSM6700 UDI BASE MODEL
WELCH ALLYN, INC.
901060
In Commercial Distribution

  • 00732094230253 ()
  • 00732094151350 ()
67MCXP

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094230239

67MCXX VSM6700 UDI BASE MODEL
WELCH ALLYN, INC.
901060
In Commercial Distribution

  • 00732094230239 ()
  • 00732094151343 ()
67MCXX

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094229837

67MXEX VSM6700 UDI BASE MODEL
WELCH ALLYN, INC.
901060
In Commercial Distribution

  • 00732094193596 ()
  • 00732094229837 ()
67MXEX

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094229752

67MXXX VSM6700 UDI BASE MODEL
WELCH ALLYN, INC.
901060
In Commercial Distribution

  • 00732094193510 ()
  • 00732094229752 ()
67MXXX

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094228779

68MXEP VSM6800 UDI BASE MODEL
WELCH ALLYN, INC.
901060
In Commercial Distribution

  • 00732094193015 ()
  • 00732094228779 ()
68MXEP

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094228755

68MXEX VSM6800 UDI BASE MODEL
WELCH ALLYN, INC.
901060
In Commercial Distribution

  • 00732094192995 ()
  • 00732094228755 ()
68MXEX

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094228670

68MXXX VSM6800 UDI BASE MODEL
WELCH ALLYN, INC.
901060
In Commercial Distribution

  • 00732094192926 ()
  • 00732094228670 ()
68MXXX

  • Multiple vital physiological parameter monitoring system, clinical

BCI - 15019517053708

No Description
ICU MEDICAL, INC.
3375
In Commercial Distribution

  • 15019517053708 ()


  • Multiple vital physiological parameter monitoring system, clinical

SIUI - 06938396423025

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2300S
In Commercial Distribution

  • 06938396423025 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396423018

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2300
In Commercial Distribution

  • 06938396423018 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396410063

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1000S
In Commercial Distribution

  • 06938396410063 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396410049

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1000
In Commercial Distribution

  • 06938396410049 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396400767

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2300T
In Commercial Distribution

  • 06938396400767 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396400446

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2100S
In Commercial Distribution

  • 06938396400446 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396400439

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2100
In Commercial Distribution

  • 06938396400439 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396400422

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1100S
In Commercial Distribution

  • 06938396400422 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396400415

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-1100
In Commercial Distribution

  • 06938396400415 ()


  • Portable basic diagnostic x-ray system, digital

Amimon - 00860014100673

MD52 Rx device
Amimon Inc.
MD52 Rx device - MDWL2_B3P1RX
In Commercial Distribution

  • 00860014100673 ()
MDWL2_B3P1RX

  • Medical image management system

Amimon - 00860014100666

MD52 Tx device
Amimon Inc.
MD52 Tx device - MDWL2_B1P1TX
In Commercial Distribution

  • 00860014100666 ()
MDWL2_B1P1TX

  • Medical image management system

Amimon - 00860014100635

MD11 Rx device
Amimon Inc.
MD11 Rx device - MDWL1_B1N1RX
In Commercial Distribution

  • 00860014100635 ()
MDWL1_B1N1RX

  • Medical image management system

Amimon - 00860014100628

MD11 Tx device
Amimon Inc.
MD11 Tx device - MDWL1_C1N1TX
In Commercial Distribution

  • 00860014100628 ()
MDWL1_C1N1TX

  • Medical image management system

Amimon - 00860014100611

MD62 Rx device
Amimon Inc.
MD62 Rx device - MDWL2_B1J1RX
In Commercial Distribution

  • 00860014100611 ()
MDWL2_B1J1RX

  • Medical image management system

Amimon - 00860014100604

MD62 Tx device
Amimon Inc.
MD62 Tx device - MDWL2_B1J1TX
In Commercial Distribution

  • 00860014100604 ()
MDWL2_B1J1TX

  • Medical image management system

Vitazi.ai Telehealth Portal - 00860012221608

Vitazi Telehealth Portal is web-facing software used to screen patients for diabetic retinopathy (DR). The Vitazi Telehealth Portal is a software medical device. The purpose of the Vitazi Telehealth Portal is to allow licensed medical providers to review and interpret medical images.
Vitazi.Ai, Inc.
0.0.8
In Commercial Distribution

  • 00860012221608 ()


  • Medical image management system

GutTracker - 00860011391500

GutTracker measures GI motility of the stomach, small intestine and colon non-invasively over multiple days as patients go about their normal daily lives.The intended use for the G-Tech Patch System is to serve as a tool that provides gastrointestinal myoelectrical activity measurements to be used at the discretion of the Physician or Clinical User to aid in the diagnosis and evaluation of gastrointestinal disorders.
G-TECH MEDICAL, INC.
Gen 2
In Commercial Distribution

  • 00860011391500 ()
  • 00860011391517 ()

  • Length: 3.3 Inch
1001

  • Wearable multiple vital physiological parameter monitoring system

Sirona Medical Radiology Platform - 00860011175803

No Description
Sirona Medical, Inc.
Model1
In Commercial Distribution

  • 00860011175803 ()


  • Radiology information system

AS-EMR SYSTEM; AS-OBGYN INFORMATION SYSTEM - 00860010575307

The AS-OBGYN Information System is a PACS system that automates the managment of patient information. It is intended to be used by obstetricians, gynecologists, perinatologists, radiologists, and cardiologists.
Asw Software, LLC
10
In Commercial Distribution

  • 00860010575307 ()


  • Ultrasound imaging system application software

Spire Health Remote Patient Monitoring System - 00860008932204

The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically relevant patient health data.
CONVEXITY SCIENTIFIC LLC
700099
In Commercial Distribution

  • 00860008932204 ()


  • Wearable multiple vital physiological parameter monitoring system

ZOLL Arrhythmia Management System - 00855778005463

No Description
ZOLL MANUFACTURING CORPORATION
Gateway (4G)
In Commercial Distribution

  • 00855778005463 ()
10A1112

  • Wearable multiple vital physiological parameter monitoring system

uCor Heart Failure and Arrhythmia Management System - 00855778005456

No Description
ZOLL MANUFACTURING CORPORATION
Gateway (4G)
In Commercial Distribution

  • 00855778005456 ()
10A1107

  • Wearable multiple vital physiological parameter monitoring system
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